nuvigil pregnancy registry lasuna

Pregnancy exposure registries have been developed to collect health information on exposure to medical products (such as drugs and vaccines ) during pregnancy. fetal ultrasound, serum markers).Retrospective is define per protocol: retrospective data of pregnancy exposure are data acquired after the outcome of the pregnancy is known or after the detection of a congenital malformation on prenatal test.Major birth defects using Metropolitan Atlanta Congenital Birth Defects Program (MACDP) definitionsInitial reporter (e.g., patient or healthcare professional)The Registry is designed for open enrollment of all patients who meet the inclusion criteria. There are no controlled data in human pregnancy. The NUVIGIL Pregnancy Registry has been established to evaluate the safety of NUVIGIL use during pregnancy. In addition, patient support groups or condition-related sources of information may be targeted to raise patient awareness of the Registry.Keywords provided by Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. ): Participation in the Registry is entirely voluntary, and you may withdraw at any time. We comply with the HONcode standard for trustworthy health information - You have reached the maximum number of saved studies (100).Please remove one or more studies before adding more.Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )The primary objective of the Nuvigil/Provigil Pregnancy Registry is to characterize the pregnancy and fetal outcomes associated with Nuvigil and Provigil exposure during pregnancy.Both prospective and retrospective data are captured.Prospective is defined per protocol: prospective data of pregnancy exposure are data acquired prior to the knowledge of the pregnancy outcome or prior to the detection of a congenital malformation at prenatal examination (e.g. How to enroll? The PROVIGIL Pregnancy Registry has been established to evaluate the safety of PROVIGIL use during pregnancy.To learn more about the PROVIGIL Pregnancy Registry, contact a Registry representative at 1-866-404-4106 (toll-free). Welcome to the PROVIGIL Pregnancy Registry Web site. These databases can be helpful resources for researchers and regulatory agencies. Animal studies for modafinil have also revealed development toxicity at doses from 20 to 200 mg/kg/day; however, a study with a 480 mg/kg/day dose demonstrated no adverse effects on embryofetal development. There are no controlled data in human pregnancy. Available for Android and iOS devices. Appendix XII: Pregnancy Registries . Select one or more newsletters to continue. The function and activities of the Nuvigil/Provigil Pregnancy Registry will be publicized through direct mailings to obstetricians and pharmacists. To learn more about the NUVIGIL Pregnancy Registry, contact a Registry representative at 1-866-404-4106 (toll-free). Pregnancy Registry : There is a registry for women who become pregnant during treatment with NUVIGIL. For ongoing awareness, information on the Registry will be included in the prescribing information and in the Medication Guides distributed by the pharmacist at the time of dispensing. The primary objective of the Nuvigil/Provigil Pregnancy Registry is to characterize the pregnancy and fetal outcomes associated with Nuvigil and Provigil exposure during pregnancy. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. As a result French and Canadian health officials have recommended that pregnant women, and women who are trying to become pregnant, not take modafinil. In animal studies for this drug, developmental toxicity (increased fetal visceral and skeletal variations, decreased fetal body weight) was observed at clinically relevant plasma exposures and at a dose of 600 mg/kg/day. TEVA Pharmaceuticals has recently reported on the results of the 2018 annual report of the ongoing Nuvigil/Provigil (modafinil) Pregnancy Registry in the United States. Fertility information is not available for this drug, but oral administration of modafinil produced an increase in the time to mate at the 480 mg/kg/day dose; no other fertility effects were observed. The Nuvigil® and Provigil® Registry (NCT01792583; ClinicalTrials.gov) is a prospective, observational study in the United States (US) to characterise the pregnancy and foetal outcomes associated with modafinil/armodafinil exposure from six weeks prior to conception and/or during pregnancy. COVID-19 is an emerging, rapidly evolving situation. This drug should be used during pregnancy only if the potential benefit justifies the possible risk to the fetus.Intrauterine growth restriction and spontaneous abortion have been reported with this drug and modafinil. To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Major birth defects are the primary endpoint of the Click here for … An interim data analysis from the US Nuvigil (armodafinil) and Provigil (modafinil) Pregnancy Registry revealed of 78 prospective pregnancy cases, 61 live births were recorded, of which 9 had a major congenital anomaly. A toll-free phone line will be established for patient enrollment and a website containing information about the Registry for both physician and patient recruitment will be available.

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